FDA 483 - BrightGene Fine Chemical Co., Ltd (Tongyuan Road) - January 20, 2024

BrightGene Fine Chemical Co. Ltd. in Taizhou, Jiangsu, China, received a Form FDA 483 with six observations following an inspection from January 15-20, 2024. The inspection revealed significant deficiencies across manufacturing process validation, quality unit oversight, laboratory controls, equipment maintenance, and supplier qualification. These issues indicate a systemic failure to adhere to cGMP requirements for intermediates and active pharmaceutical ingredients, with some observations being repeats from previous inspections.